Registration of Medical Devices Establishments

Medical devices play a critical role in the diagnosis, management and prevention of disease. It is therefore critical that available medical devices should be safe and high-quality and perform as intended by the originating manufacturer throughout their life cycle. The International Organization for Standardisation (ISO) standard ISO 13485:2016 (Medical devices – quality management systems – requirements for regulatory purposes) is widely accepted by regulators as the basis of the appropriate quality management systems requirements for medical devices establishments that need to demonstrate their ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services throughout the product life- cycle.

The medical devices establishment is expected to have an established quality management system to ensure continued safety, quality and performance of all medical devices throughout the product’s life cycle and within the supply chain. The registration of the establishment is one of the processes which ensures that the manufacturer, importer and/or distributor fulfils the regulatory requirements, as determined through the legislative framework informing the control of medical devices.

This Guideline provides the framework for Registration of Medical devices Establishments under the Pharmacy and Poisons Act. It should be read alongside other relevant guidance documents and other relevant legislation.